FDA Launches New Quality/Compliance Web Content

FDA's Office of Compliance and Biologics Quality (QCBQ) within the Center for Biologics Evaluation and Research (CBER) has launched a web page describing responsibilities such as inspection, surveillance, and compliance to pre- and post- market approval activities.

PPTA News

Monkeypox Virus and Plasma Protein Therapies +

PPTA considers that the current MPXV outbreak is not a concern for the safety margins of plasma protein therapies manufactured by PPTA member companies. This assessment is also shared by other concerned parties (AABB, WHO).

Since May 2022, Monkeypox virus (MPXV) infections have been reported in non-endemic countries across Europe and North America (WHO, CDC, ECDC). People who use plasma protein therapies are understandably concerned about whether their therapies remain safe, with respect to MPXV. To address this issue, PPTA has summarized currently available facts.
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Announcing PPTA’s New Global Chair +

It is with great pleasure that the Plasma Protein Therapeutics Association (PPTA) announces the election of Giles Platford from Takeda to the Chair of the PPTA Global Board.
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Public Review until August 13: Proposed Confirmation of IQPP Standard for Recording Donor Adverse Events +
The following proposed actions are hereby opened for public review:
- Confirmation (continued implementation) of Version 2.0 of the IQPP Standard for Recording Donor Adverse Events
Resulting from a scheduled review by the PPTA IQPP Standards Committee and discussion by the PPTA Global Plasma Board of Directors, it was agreed that this document should be “confirmed.” In other words, it was agreed that the document should continue to be implemented as part of the IQPP Standards Program, without change. Members of the public are invited to comment on this proposed action. The text of the standards themselves is not being considered for revision at this time.
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PPTA's 2021 Annual Report Now Available +

On March 16, PPTA published its 2021 Annual Report, providing an overview of the Association’s activities throughout the year. This year’s digital report offers readers an engaging and interactive experience as they read about PPTA’s work on behalf of its global membership and in support of patients who rely on plasma-derived therapies. We invite you to read the report here.
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The Source, the international magazine of the plasma protein therapeutics industry, is published three times a year.

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"How Is Your Day?" is an initiative to raise awareness of the unique nature of plasma protein therapies and the value they provide to patients. It aims to inform and educate decision makers and the general public worldwide.

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FDA Launches New Quality/Compliance Web Content

Monkeypox Virus and Plasma Protein Therapies +

Announcing PPTA’s New Global Chair +

Public Review until August 13: Proposed Confirmation of IQPP Standard for Recording Donor Adverse Events +

PPTA's 2021 Annual Report Now Available +

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